A Phase 3 interventional study of Mifepristone and matching placebo in Major Depressive Disorder and Psychotic Disorders, sponsored by Corcept Therapeutics. Completed at 23 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-15.
Sponsored by Corcept Therapeutics · Phase 3, Interventional, and Treatment
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 257 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals eligible for enrollment into this study are male and female adult patients who:
Exclusion Criteria:
Individuals not eligible to be enrolled into the study are those who:
Drug: Mifepristone
Drug: matching placebo
daily for 7 days
daily for 7 days
The change in a measure of psychosis
Time frame: screening and on Days 0, 7, 14, 28, 42, and 56
The change in a measure of depression
Time frame: screening and on Days 0, 7, 14, 28, 42, and 56
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Corcept Therapeutics